DORMIDINA DOXILAMINE 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Dormidinadoxilamine12.5mg film-coated tablets

Doxylamine hydrogen succinate

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the package leaflet

1. What is Dormidina doxylamine and what is it used for
2. What you need to know before taking Dormidina doxylamine
3. How to take Dormidina doxylamine
4. Possible side effects

5 Conservation of Dormidina doxylamine

1. Contents of the pack and further information

1. What is Dormidina doxylamine and what is it used for

Dormidina doxylamine is a medicine that contains the active ingredient doxylamine hydrogen succinate. Doxylamine belongs to a group of medicines called antihistamines, which have sedative properties.

It is indicated for the symptomatic treatment of occasional insomnia in adults over 18 years of age.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Dormidina doxylamine

Do not take Dormidinadoxylamine

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• If you are allergic to other antihistamines.
• If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dormidina doxylamine.

You should consult a doctor before taking this medicine if you have:

• liver and kidney function disorders
• epilepsy
• prolongation of the QT interval (a heart problem)
• low potassium levels in the blood or other electrolyte disorders
• heart disease and high blood pressure
• asthma, chronic bronchitis (persistent inflammation of the bronchi) and pulmonary emphysema (a disease that affects the lungs, making breathing difficult)
• glaucoma (increased eye pressure)
• urinary retention
• prostatic hypertrophy (abnormal enlargement of the prostate)
• peptic ulcer (erosion of the stomach or duodenum wall), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine), and obstruction of the bladder neck (a disease of the urinary tract)

• If you experience daytime drowsiness, it may be necessary to reduce the dose or take it earlier to ensure that at least 8 hours pass until waking time.
• Alcohol consumption should be avoided during treatment.
• If you are over 65 years old, you may be more susceptible to side effects.
• Dormidina doxylamine may worsen dehydration and heat stroke symptoms due to decreased sweating.

Taking Dormidinadoxylaminewith other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or may take any other medicine.

Do not take Dormidina doxylamine with the following medicines, as their effects may be enhanced:

• Epinephrine (for low blood pressure treatment).
• Medicines that act on the heart, such as those used to treat arrhythmias, some antibiotics, certain antimalarial drugs, certain antihistamines, certain lipid-lowering agents, or certain neuroleptics (medicines for mental disorders).
• Medicines that decrease the elimination of others, such as azole derivatives or macrolides, as they may increase the effect of Dormidina doxylamine.
• Certain diuretics (medicines that increase urine elimination).
• Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine).
• Antihypertensive agents with a central nervous system effect, such as guanabenz, clonidine, or alpha-methyldopa.
• Other anticholinergic drugs, such as those used to treat depression or Parkinson's disease, monoamine oxidase inhibitors (antidepressants), neuroleptics (medicines for mental disorders), antispasmodic atropine-like medicines, or disopyramide (for certain heart problems).
• If you are taking other medicines that can cause ear toxicity, such as carboplatin or cisplatin (cancer medicines), chloroquine (a medicine for the treatment or prevention of malaria), or certain antibiotics (such as erythromycin or injectable aminoglycosides), among others; Dormidina doxylamine may mask the toxic effects of these medicines, so you should periodically review the condition of your ears.

Interference with diagnostic tests

Doxylamine may interfere with skin allergy tests that use allergens. It is recommended to discontinue treatment with Dormidina doxylamine at least three days before starting such tests.

Taking Dormidinadoxylaminewith food, drink, and alcohol

Alcoholic beverages should not be consumed during treatment with Dormidina doxylamine.

See section 3. How to take Dormidina doxylamine

Pregnancy,breastfeeding,and fertility

Do not take Dormidina doxylamine if you are pregnant, plan to become pregnant, or are breastfeeding.

No data are available on the possible effects of Dormidina doxylamine on human fertility.

Driving and using machines

The influence of Dormidina doxylamine on the ability to drive and use machines is significant. Do not drive or use hazardous machinery while taking this medicine, at least during the first days of treatment, until you know how it affects you.

Dormidinadoxylaminecontains cochineal red A.

This medicine may cause allergic reactions because it contains cochineal red A. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

Sodium content

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Dormidina doxylamine

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Adults (over 18 years old)

The recommended dose is 1 to 2 tablets (12.5 mg to 25 mg) per day.

If daytime drowsiness occurs, it is recommended to reduce the dose to 1 tablet (12.5 mg) or take it earlier to ensure that at least 8 hours pass until waking time.

Do not take more than 2 tablets (25 mg) per day.

Use in the elderly

People over 65 years old are more likely to suffer from other diseases that may recommend a dose reduction. In case of unwanted side effects, the dose will be 1 tablet (12.5 mg) per day.

Use in patients with liver or kidney disease

These patients should take a different dose, adjusted to the degree of their disease, which will be determined by the doctor.

Use in childrenand adolescents

Dormidina doxylamine is not recommended for use in children under 18 years old, so the medicine should not be used in this population.

Route and method of administration

Oral route.

The tablets should be taken 30 minutes before bedtime with a sufficient amount of liquid (preferably water).

Dormidina doxylamine can be taken before or after meals.

Duration of treatment

The duration of treatment should be as short as possible. In general, the duration of treatment may range from a few days to a week.

It should not be administered for a period exceeding 7 days without consulting a doctor.

If you take more Dormidinadoxylaminethan you should

The symptoms of an overdose are: drowsiness, depression or stimulation of the central nervous system, anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal tone), flushing, increased or altered heart rate, increased blood pressure, nausea, vomiting, agitation, alteration of gait, dizziness, irritability, sedation, confusion, and hallucinations. Delirium, psychosis, decreased blood pressure, convulsions, decreased respiration, loss of consciousness, coma, and death may occur. A serious complication can be rhabdomyolysis (muscle damage), followed by kidney failure.

There is no specific antidote for antihistamine overdose, so treatment is symptomatic and supportive. Your doctor will assess the need to induce vomiting, perform gastric lavage, or prescribe medications to increase blood pressure if necessary.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91.562.04.20.

If you forget to take Dormidinadoxylamine

Do not take a double dose to make up for forgotten doses.

Take your dose at the usual time the next day.

If you stop taking Dormidinadoxylamine

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dormidina doxylamine can cause side effects, although not everybody gets them.

The side effects of doxylamine are generally mild and transient, being more frequent in the first days of treatment.

Common side effects (may affect up to 1 in 10 people): drowsiness and effects such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, vertigo, dizziness, headache, abdominal pain, fatigue, insomnia, and nervousness.

Uncommon side effects (may affect up to 1 in 100 people): asthenia (fatigue), peripheral edema (inflammation of arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (decrease in blood pressure due to postural changes), diplopia (double vision), dyspepsia (stomach disorders), feeling of relaxation, nightmares, and dyspnea (breathing difficulties).

Rare side effects (may affect up to 1 in 1,000 people): agitation (especially in children and the elderly), tremors, convulsions, or blood disorders such as hemolytic anemia, thrombocytopenia, leukopenia, or agranulocytosis (decrease in certain blood cells).

Side effects of unknown frequency (cannot be estimated from available data): general malaise.

Other side effects that have occurred with the use of antihistamines in general, although not observed with doxylamine, are the following: arrhythmia (alteration of heart rate), palpitations, duodenogastric reflux, abnormal liver function (cholestatic jaundice), prolonged QT interval on the electrocardiogram (a cardiac disorder), decreased appetite, increased appetite, myalgia (muscle pain), abnormal coordination, extrapyramidal disorder (movement disorders), paresthesia (abnormal sensations), psychomotor activity impairment (coordination of senses and movement), depression, decreased bronchial secretion, alopecia (hair loss), allergic dermatitis, hyperhidrosis (excessive sweating), photosensitivity reaction, or hypotension (low blood pressure).

The frequency and magnitude of side effects can be reduced by decreasing the daily dose.

People over 65 years old have a higher risk of suffering from adverse reactions, as they may have other diseases or may be taking other medicines simultaneously. These people also have a higher risk of falls.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting of side effects:

If you experience any side effects, consult your doctor, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Dormidina doxylamine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box or blister after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicinal products in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Contents of the pack and further information

Composition of Dormidinadoxylamine

• The active substance is doxylamine hydrogen succinate. Each tablet contains 12.5 mg of doxylamine hydrogen succinate.
• The other components are:

Core excipients:

Dicalcium phosphate dihydrate (E-341)

Microcrystalline cellulose (E-460)

Sodium carboxymethyl starch (type A) of potato

Colloidal anhydrous silica (E-551)

Magnesium stearate (E-572)

Coating excipients:

Microcrystalline cellulose (E-460)

Poloxamer 407 (E-431)

Propylene glycol (E-1520)

Hypromellose (E-464)

Titanium dioxide (E-171)

Cochineal red A (E-124) (see section 2 "Dormidina doxylamine contains cochineal red A" )

Polyethylene glycol 400

Polyethylene glycol 6000

Appearance of the product and contents of the pack

Dormidina doxylamine is presented in the form of pink, film-coated, elongated tablets, in packs containing 7 or 14 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer

Towa Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona) Spain

Date of last revision of this leaflet August 2012.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/